System and method for adjusting a gas delivery mask

ABSTRACT

A system for adjusting a gas delivery mask is provided. The system may include a base, an arm pivotally coupled to the base, and an intermediate member slidably coupled to both the base and the arm. The arm may include a first threaded portion, and the intermediate member may include a second threaded portion coupled to the first threaded portion. Rotation of the second threaded portion relative to the first threaded portion may slide the intermediate member along the arm and relative to the base such that the arm pivots relative to the base.

TECHNICAL FIELD

The present disclosure is related to systems and methods for adjusting agas delivery mask, e.g., a continuous positive airway pressure (CPAP)mask.

BACKGROUND

In recent years, continuous positive airway pressure (CPAP) therapy hasbecome a common prescription for individuals suffering from sleep apneaand/or other breathing ailments. Such therapy may involve placement of anose or face mask on the subject during sleeping, while positivepressure air is continuously delivered to the subject through the mask.In some cases, such CPAP treatment may materially lessen the incidentsand/or severity of sleep apnea, thereby allowing the subject to sleep orrest with less disturbances.

A common problem encountered with prior CPAP nose mask assemblies is thetendency to leak positive pressure air at one or more locations, such asbetween connections of mask assembly components and/or between the maskassembly and the subject's face, e.g., where the cheek regions and noseintersect. Leaks between the mask and the subject's face areparticularly common due to the wide ranges of shapes and sizes of theheads and faces of different subjects. Leaks within a mask assembly orbetween the mask assembly and the subject's face may be undesirable forvarious reasons. For example, leaks may reduce the positive pressure ofthe air being delivered to the subject. As another example, leaksbetween the mask and the subject's face may tends to dry the subject'seyes, creating uncomfortable wearing and operating conditions. Asanother example, leaks may produce noises, which may be undesirable tothe subject and/or the subject's bed partner. One typical way to reduceleaks is to provide a tighter compressive fit of the mask against thenose and face of the wearer. However, too tight of a fit may causediscomfort to the subject.

SUMMARY

In accordance with the present disclosure, systems and methods foradjusting a gas delivery mask, e.g., a continuous positive airwaypressure (CPAP) mask, are provided.

In accordance with one embodiment of the present disclosure, a systemfor adjusting a gas delivery mask is provided. The system may include abase, an arm pivotally coupled to the base, and an intermediate memberslidably coupled to both the base and the arm. The arm may include afirst threaded portion, and the intermediate member may include a secondthreaded portion coupled to the first threaded portion. Rotation of thesecond threaded portion relative to the first threaded portion may slidethe intermediate member along the arm and relative to the base such thatthe arm pivots relative to the base.

In accordance with another embodiment of the present disclosure, a gasdelivery mask apparatus is provided. The mask apparatus may include arigid mask base, a face mask configured to deliver gas to the subject,and a rigid mask arm. The rigid mask arm may be rotationally coupled tothe mask base proximate a first end by a pivot joint having an axisextending laterally across the mask base. The rigid mask arm may also becoupled to the face mask proximate a second end and configured tosupport a gas flow tube for delivering gas to the face mask.

In accordance with another embodiment of the present disclosure, asystem for adjusting a gas delivery mask is provided. The system mayinclude rigid base means for supporting a gas delivery mask adjacent asubject's head, gas delivery means for delivering gas to the subject,and rigid supporting means for supporting the gas delivery means. Therigid supporting means may be rotatably coupled to the rigid base meansabout a pivot joint having an axis extending laterally across the rigidbase means.

BRIEF DESCRIPTION OF THE DRAWINGS

Some embodiments of the disclosure may be understood by referring, inpart, to the following description and the accompanying drawings, inwhich like reference numbers refer to the same or like parts, andwherein:

FIG. 1 illustrates a side view of a gas delivery mask apparatus,according to certain embodiments of the disclosure;

FIG. 2 illustrates a three-dimensional view of a gas delivery maskapparatus, according to one particular embodiment of the disclosure;

FIGS. 3A-3B illustrate a system for securing an example embodiment of amask apparatus onto a subject's head, according to one embodiment of thedisclosure;

FIG. 4 illustrates a three-dimensional exploded view of a maskapparatus, according to one particular embodiment of the disclosure;

FIG. 5 is a three-dimensional view of a portion of a mask assemblyillustrating an arm adjustment system, according to one embodiment ofthe disclosure;

FIG. 6 is a three-dimensional view of a portion of a mask assemblyillustrating the attachment of a face mask to an arm assembly, accordingto one embodiment of the disclosure;

FIGS. 7A-7B illustrate an example ball joint for providing flexibilityto a gas delivery pathway, according to one embodiment of thedisclosure;

FIGS. 8A-8D illustrate an example configuration of a gasket, accordingto one embodiment of the disclosure;

FIG. 9 illustrates an example configuration of a mask base, according toone embodiment of the disclosure;

FIG. 10 illustrates an example configuration of a base pad, according toone embodiment of the disclosure;

FIG. 11 illustrates an example configuration of a hook and loop fastenersheet, according to one embodiment of the disclosure;

FIG. 12 illustrates an example configuration of a strap portion of ahead strap, according to one embodiment of the disclosure;

FIGS. 13A and 13B illustrate two views of an example configuration of acord portion of a head strap, according to one embodiment of thedisclosure;

FIG. 14 illustrates an example configuration of a lever, according toone embodiment of the disclosure;

FIGS. 15A-15B illustrate an example configuration of an arm member,according to one embodiment of the disclosure;

FIG. 16 illustrates an example configuration of a body portion of anintermediate member, according to one embodiment of the disclosure;

FIG. 17 illustrates an example configuration of a threaded portion of anintermediate member, according to one embodiment of the disclosure;

FIGS. 18A-18B illustrate an example configuration of a front elbowportion, according to one embodiment of the disclosure;

FIGS. 19A-19B illustrate an example configuration of an exhaust port,according to one embodiment of the disclosure;

FIG. 20 illustrates an example configuration of a slider seal, accordingto one embodiment of the disclosure;

FIGS. 21A-21B illustrate an example configuration of a rear elbowportion, according to one embodiment of the disclosure;

FIG. 22 illustrates an example configuration of a clip, according to oneembodiment of the disclosure;

FIG. 23 illustrates an example configuration of a bottom housing of aball joint, according to one embodiment of the disclosure;

FIGS. 24A-24B illustrate an example configuration of a seal/spring,according to one embodiment of the disclosure;

FIGS. 25A-25B illustrate an example configuration of a top housing of aball joint, according to one embodiment of the disclosure;

FIGS. 26A-26B illustrate an example configuration of a ball body,according to one embodiment of the disclosure; and

FIGS. 27A-27B illustrate an example configuration of a ball cap,according to one embodiment of the disclosure.

DETAILED DESCRIPTION

Selected embodiments of the disclosure may be understood by reference,in part, to FIGS. 1-27, wherein like number refer to same and likeparts.

FIG. 1 illustrates a side view of a gas delivery mask apparatus 10according to certain embodiments of the disclosure. Gas delivery maskapparatus 10 may be generally configured to assist a subject withbreathing by delivering gas to the subject and/or removing gas from asubject, for example. In a particular application, mask apparatus 10 maybe used to provide constant positive air pressure (CPAP) to a subject,such as to treat an apnea or other breathing condition. In certainembodiments, such as described herein, mask apparatus 10 may be securedto the subject's head.

In various embodiments, gas delivery mask apparatus 10 may include one,some or all of the following features:

(a) a mask base 12, e.g., to support mask apparatus 10 against asubject's head;

(b) a cushioned face mask 14 that may interface with the subject's face,such as around the nose and/or mouth openings;

(c) an arm assembly 16 that may support face mask 14;

(d) a head strap 20 to, e.g., secure mask apparatus 10 on the subject'shead;

(e) a mask securing system 22 to, e.g., tighten and/or untighten headstrap 20 around the subject's head,

(f) one or more adjustment systems 24 to, e.g., adjust the position offace mask 14 against the subject's face;

(g) a gas delivery pathway 28 to, e.g., deliver one or more gases toand/or from the subject via face mask 14;

(h) a gas pathway flexibility system 30 to, e.g., provide increasedflexibility to gas delivery pathway 28; and/or

(i) a gas exhaust system 32 to, e.g., remove exhaled gas away from thesubject.

It should be understood that in various embodiments, gas delivery maskapparatus 10 may include any combination of one, some or all of theselisted features (a)-(i) and/or any one or more additional features. Forexample, in certain embodiments (such as the embodiment shown anddiscussed below with reference to FIG. 2, for example), gas deliverymask apparatus 10 may include all of the listed features (a)-(i). Inanother example embodiment, mask apparatus 10 may include each listedfeature except feature (f). In another example embodiment, maskapparatus 10 may include each listed feature except features (e) and(h).

The one or more adjustment systems 24 to, e.g., adjust the positioningof face mask 14 against the subject's face may include one or more ofthe following: (a) an arm adjustment system 40 to, e.g., adjust armassembly 16 relative to the mask body 12 and/or the subject's head, (b)a face mask adjustment system 42 to, e.g., adjust the orientation offace mask 14 relative to arm assembly 16, and (c) a gasket 44 that mayprovide flexibility between arm assembly 16 and face mask 14. Again, itshould be understood that in various embodiments, gas delivery maskapparatus 10 may include none, one, or any combination of some or all ofadjustment systems 40, 42 and 44 and/or any one or more systems foradjusting the positioning of face mask 14 against the subject's face.For example, in certain embodiments (such as the embodiment shown anddiscussed below with reference to FIG. 2, for example), mask apparatus10 may include adjustment systems 40, 42 and 44. In another exampleembodiment, mask apparatus 10 may include arm adjustment system 40 andgasket 44, but not face mask adjustment system 42. In another exampleembodiment, mask apparatus 10 may include gasket 44 and face maskadjustment system 42, but not arm adjustment system 40.

Gas delivery pathway 28 may include any one or more gas deliveryconduits for delivering gas to and/or from the subject via face mask 14.For example, gas delivery pathway 28 may include any one or more gasdelivery conduits for delivering gas from a gas source, such as a tank,ventilator, or wall line, for example, to the subject via face mask 14.Gas delivery pathway 28 may also include one or more conduits forcarrying exhaled gas away from the subject. As used herein, the term“gas” may refer to any one or more gases and/or vaporized substancessuitable to be delivered to and/or from a subject via one or morebreathing orifices (e.g., the nose and/or mouth), such as air, nitrogen,oxygen, any other component of air, CO₂, vaporized water, vaporizedmedicines, and/or any combination of two or more of the above, forexample.

Gas pathway flexibility system 30 may include any system for providingincreased flexibility to one or more components of gas delivery pathway28. For example, in certain embodiments (such as the embodiment shownand discussed below with reference to FIG. 2, for example), gas pathwayflexibility system 30 may include one or more ball joints 50 locatedbetween components of gas delivery pathway 30 to, e.g., increase theflexibility between such components.

Gas exhaust system 32 may include any system for removing exhaled gasaway from the subject. For example, in certain embodiments (such as theembodiment shown and discussed below with reference to FIG. 2, forexample), gas exhaust system 32 may include a gas exhaust member 52configured to allow gas exhaled by the subject (e.g., CO₂) to escapefrom mask apparatus 10 into the surrounding environment.

In some embodiments, mask apparatus 10 may be a component of a breathingfacilitation system that may facilitate or otherwise affect a subject'sbreathing, e.g., a CPAP system. Such a breathing facilitation system mayinclude a mask apparatus 10, a gas (e.g., air) source, and/or one ormore gas delivery conduits coupling mask apparatus 10 to the gas sourcesuch that gas may be delivered from the gas source to the subject viamask apparatus 10. The one or more gas delivery conduits may include allor portions of gas delivery pathway 28 and/or one or more addition gasdelivery conduits or components for communicating gas between the gassource and mask apparatus 10. The gas source may be any device ordevices configured to generate and/or supply gas (e.g., pressurized air)to a subject via mask apparatus 10. In some embodiments, the gas sourcemay be configured to generate and/or supply pressurized gas (e.g.,pressurized air) to a subject via mask apparatus 10. For example, thepressurized gas source may include a stand-alone unit capable ofgenerating pressurized air (e.g., by pressurizing atmospheric air), awall outlet through which pressurized air may be supplied (e.g., in ahospital or clinic), a tank of compressed air, or any other suitablesource of pressurized air. In other embodiments, the gas source may beconfigured to generate and/or supply generally non-pressurized gas(e.g., atmospheric air), e.g., where breathing facilitation system isconfigured to provide clean or fresh air to a subject.

In addition, in some embodiments, the breathing facilitation system mayinclude one or more devices to treat or condition the gas beingdelivered to the subject. For example, the breathing facilitation systemmay include one or more filters configured to filter the gas beingdelivered to the subject, a humidifier configured to humidify the gasbeing delivered to the subject, a heater or cooler configured to adjustand/or control the temperature of gas being delivered to the subject,and/or a medicine delivery device configured to deliver a medication(e.g., in vapor form) into the gas being delivered to the subject. Inaddition, in some embodiments, the breathing facilitation system mayinclude a controller configured to control various parameters of theoperation of the breathing facilitation system (e.g., to control variousparameters of the operation of the pressurized gas source), and/or oneor more sensors or other devices configured to provide feedback to thecontroller for regulating the operation of the breathing facilitationsystem. It should be understood that the breathing facilitation systemmay include any combination of one, some or all of the componentsdiscussed above and/or any one or more additional suitable components.

FIG. 2 illustrates a three-dimensional view of a gas delivery maskapparatus 10 according to one particular embodiment of the disclosure.In this particular embodiment, mask apparatus 10 may include each or anycombination of the features discussed above with reference to FIG. 1. Asshown in FIG. 2, mask apparatus 10 may include a mask body 12, a facemask 14, an arm assembly 16, a head strap 20, a mask securing system 22,an arm adjustment system 40, a face mask adjustment system 42, a gasket44, a ball joint 50, a gas exhaust member 52, and/or a base pad 60.

Mask apparatus 10 may also include a gas delivery pathway 28 to, e.g.,deliver gas to and/or from the subject via face mask 14, which mayinclude a first gas delivery conduit 62 generally located between afirst side of ball joint 50 and face mask 14, and a second gas deliveryconduit 64 extending from a second side of ball joint 50. First gasdelivery conduit 62 and second gas delivery conduit 64 are shown inFIGS. 3A-3B (discussed below), but are not shown in FIG. 2 in order tobetter illustrate the details of and interaction between othercomponents of mask apparatus 10. First gas delivery conduit 62 and/orsecond gas delivery conduit 64 may have any suitably configuration andmay be formed from any suitable material for conducting gas along gasdelivery pathway 28. In some embodiments, first gas delivery conduit 62and/or second gas delivery conduit 64 may be flexible. For example,first gas delivery conduit 62 and/or second gas delivery conduit 64 maycomprise flexible tubes or hoses formed from any suitably flexiblematerial, e.g., any suitably plastic, polymer, rubber or silicone.

Mask body 12 may be generally configured to be mounted against asubject's head (e.g., the forehead) and to, e.g., support various othercomponents of mask apparatus 10, including, e.g., arm assembly 16, headstrap 20, mask securing system 22, arm adjustment system 40, and/or balljoint 50. Base pad 60 may be coupled to the underside of mask body 12and, e.g., may provide cushioning between mask body 12 and the subject'shead, which may provide increased comfort to the subject. One embodimentof a mask body 12 is illustrated and discussed in greater detail belowwith reference to FIG. 9.

Face mask 14 may be generally configured to be supported by arm assembly12 and may interface with the subject's face, such as around the noseand/or mouth openings, to deliver gas to and/or remove gas from thesubject. In this particular embodiment, gas may be delivered to thesubject via a gas delivery pathway 28 that may include a gas source (notshown), first gas delivery conduit 62 (see FIGS. 3A-3B), ball joint 50,second gas delivery conduit 64 (see FIGS. 3A-3B), an elbow 66 of armassembly 16, gasket 44, and/or face mask 14.

In certain embodiments, face mask 14 may include a relatively rigid baseportion 68 and/or a flexible, or pliable, cushion portion 70 coupled tobase portion 68. Cushion portion 70 may be shaped and/or contoured tocomfortably fit against a subject's face and/or to reduce or minimizethe amount of gas that escapes from between cushion portion 70 and thesubject's face. For example, cushion portion may have a 3-dimensionalcontour designed to fit against the contours of a subject's face.

In some embodiments, cushion portion 70 may be substantially flexible orpliable. For example, cushion portion 70 may be formed from asubstantially flexible or pliable plastic, polymer, or silicone. Incontrast, base portion 68 may be substantially rigid relative to cushionportion 70. For example, base portion 68 may be formed from a plastic orpolymer more rigid than cushion portion 70.

Arm assembly 16 may be generally configured to support and/or align facemask 14 in position against the subject's face. Arm assembly 16 may alsosupport or be integrated with first gas delivery conduit 62, which maycomprise a flexible conduit to, e.g., communicate gas between ball joint50 and face mask 14. Arm assembly 16 may include any suitable number ofdistinct components. For example, in the embodiment shown in FIG. 2, armassembly 16 may include an elongated arm member 72 coupled to elbow 66,which may include multiple distinct components.

As shown in FIG. 2, arm assembly 16 may be pivotally coupled to maskbody 12 about one or more pivot points 76 such that arm assembly 16 mayrotate about an axis extending laterally across mask body 12. Thus, whenmask apparatus 10 is secured to a subject's head, arm assembly 16 maypivot toward or away from the subject's face, e.g., such that maskapparatus 10 may be adjusted to fit the shape and size of the subject'shead and/or facial features. In addition, the subject may pivot armassembly 16 about pivot points 76 to, e.g., control the tightness offace mask 14 against the his or her face as desired. For example, thesubject may control the tightness of face mask 14 against his or herface to achieve a desired level of comfort and/or to reduce the amountof gas that escapes from between face mask 12 and the subject's face toa desirable or acceptable level. Although arm assembly 16 is shownpivotally coupled to mask body 12, in other embodiments, arm assembly 16may be otherwise coupled to mask body 12 in any suitable manner, such asslidably, slidably and pivotally, or rigidly, or a combination of thesecouplings, for example.

Arm adjustment system 40 may generally be operable to control thepositioning of arm assembly 16 relative to mask body 12. For example, inthis embodiment, arm adjustment system 40 may include an intermediatemember 78 that may be manipulated or actuated to control the rotation ofarm assembly 16 relative to mask body 12 about pivot points 76.Intermediate member 78 may include any suitable number of distinctcomponents. In the embodiment shown in FIG. 2, intermediate member 78may include a body portion 80 and a threaded portion 82 coupled (e.g.,rotatably) to body portion 80. As discussed in greater detail below withreference to FIG. 5, rotating threaded portion 82 may cause intermediatemember 78 to move (e.g., slide) relative to both mask body 12 and armmember 72, which may cause arm assembly 16 to rotate relative to maskbody 12, e.g., about pivot points 76. It should be understood that inother embodiments, intermediate member 78 may be otherwise configuredand/or may interact differently with mask body 12 and/or arm assembly 16to control the positioning of arm assembly 16 relative to mask body 12.

In addition, as discussed above, face mask adjustment system 42 may beprovided to, e.g., adjust the orientation of face mask 14 relative toarm assembly 16. In this embodiment, face mask adjustment system 42 mayinclude a pivot joint 86 formed in or by elbow 66 that may, e.g., allowface mask 14 to pivot upwards and/or downwards relative to arm assembly16. Thus, face mask 14 may be pivoted as desired by the subject, such asto achieve a desired level of comfort for the subject and/or to reducethe amount of gas that escapes from between face mask 12 and thesubject's face.

Gasket 44 may generally be configured to couple (e.g., flexibly couple)face mask 14 with arm assembly 16. Gasket 44 may be flexible, orpliable, to allow face mask 12 to move (e.g., rotate and/or translate)in various directions relative to arm assembly 16. In addition, gasket44 may provide a substantially leak-free connection between face mask 12and arm assembly 16. In this embodiment, gasket 44 may flexibly couplebase portion 68 of face mask 14 with elbow 66 of arm assembly 16.However, in other embodiments, gasket 44 may otherwise couple a facemask with an arm member or assembly. The flexible coupling may provide abetter and/or more versatile fit between face mask 12 and the subject'sface, which may provide various advantages, such as (a) allowing maskapparatus 10 to, e.g., be used by subjects having various sized and/orshaped heads, faces, and/or facial features (e.g., noses and mouths),(b) providing increased comfort to the subject, and/or (c) reducing oreliminating the amount of gas that escapes between cushion portion 70and the subject's face.

Relatively rigid base portion 68 of face mask 14 may provide asubstantially solid base for securely and/or removably attaching gasket44 to face mask 14. In the embodiment shown in FIG. 2, gasket 44 mayinclude a lip which holds against an inner surface of base portion 68such that, e.g., gasket 44 may be securely and/or removably attached tobase portion 68. In other embodiments, rather than including a separateflexible cushion and rigid base portion 68, face mask 14 may comprise asingle integrated structure. For example, face mask 14 may comprise asingle, flexible cushion. In addition, face mask 14 may be coupled toarm assembly 16 in any other suitable manner. For example, face mask 14may be directly coupled to arm assembly 16, or may be coupled to armassembly 16 by another type of gasket, a flexible bellows or gussetstructure, or any other flexible or rigid coupling structure orstructures.

Head strap 20 may include any one or more components for securing maskapparatus 10 to a subject's head. For example, in the embodiment shownin FIG. 2, head strap 20 may include a strap portion 90 configured towrap around the subject's head and a cord portion 92 coupled to strapportion 90 and configured to interact with a lever 96 and/or one or morestrap guides 94 located on mask body 12. Strap portion 90 and/or cordportion 92 may, e.g., be formed from flexible materials. In certainembodiments, cord portion 92 may be formed from a substantially flexiblematerial and strap portion 90 may be formed from a less flexible orinflexible material. For example, cord portion 92 may be formed fromelastic or a similar material, and strap portion 90 may be formed fromneoprene or a similar material.

In the embodiment shown in FIG. 2, cord portion 92 may be coupled ateach end to an eyelet 100. Cord portion 92 may be coupled to eyelets 100in any other suitable manner, such as by insert molding, for example.Each eyelet 100 may include an opening through which elongated sideportions 102 of strap portion 90 may be routed. An elongated sideportions 104 of strap portion 90 may be routed through an eyelet oropening 106 formed in mask body 12. Elongated portions 102 and 104 ofstrap portion 90 may then be folded back and coupled to strap portion 90in any suitable manner in order to secure strap portion 90 to eyelets100 and 106. For example, elongated portions 102 and 104 may includehook and loop fastener portions 110 that may be affixed to strap portion90, as shown in FIG. 2. In other embodiments, strap portion 90 may bedirectly coupled to mask body 12, eyelets 100, and/or cord portion 92.In still other embodiments, head strap 20 comprises a single, integratedstrap.

Mask securing system 22 may be generally configured to secure head strap20 around the subject's head. In some embodiments, mask securing system22 may be operable to tighten and/or untighten head strap 20 around thesubject's head. In the embodiment shown in FIG. 2, mask securing system22 may include mask body 12, head strap 20, and lever 96. Lever 96 maybe coupled (e.g., movably coupled) to mask body 12 and generallyoperable to adjust head strap 20 around a subject's head, such as totighten or loosen head strap 20 around the subject's head, for example.In the embodiment shown in FIG. 2, lever 96 may generally operate as acinch clamp to control the tightness of head strap 20 around thesubject's head. In this embodiment, lever 96 may be pivotally coupled tomask body 12 about pivot points 76, the same pivot points 76 at whicharm member 72 may be pivotally coupled to mask body 12. However, inother embodiments, lever 96 and arm member 72 may be pivotally coupledto mask body 12 at different pivot points.

Head strap 20 may be coupled to lever 96 in any suitable manner, androuted though one or more strap guides 94 formed in mask body 12 suchthat rotation of lever 96 about pivot points 76 from an open position toa closed position (lever 96 is shown in the closed position in FIG. 2)pulls portions of head strap 20 through strap guides 94, thus tighteninghead strap 20 around the subject's head. In addition, head strap 20 maybe retained by one or more strap retention members 114 formed in, orcoupled to, lever 96. In embodiments in which head strap 20 includes astrap portion 90 and a cord portion 92, cord portion 92 may be routedthrough strap guides 94 and coupled to, or retained by, strap retentionmembers 114. One embodiment of a mask securing system 22 systemadjusting head strap 20 around a subject's head, including theinteraction between a lever 96, a mask body 12, and a head strap 20, isillustrated and discussed in greater detail below with reference toFIGS. 3A and 3B.

Ball joint 50 may be generally configured to, e.g., provide increasedflexibility for gas delivery pathway 28 (see FIGS. 3A-3B). In theembodiment shown in FIGS. 2-3B, ball joint 50 may provide additionalflexibility between first gas delivery conduit 62 with second gasdelivery conduit 64. Such additional flexibility may reduce thelikelihood of gas delivery pathway 28 becoming crimped, tangled, orotherwise undesirably oriented during the movement of the subject, suchas when the subject moves or turns his or her head during sleep, forexample. One embodiment of a ball joint 50 is illustrated and discussedin greater detail below with reference to FIGS. 7A-7B.

Exhaust member 52 may be generally configured to remove exhaled gas awayfrom the subject. In the embodiment shown in FIG. 2, exhaust member 52may be integrated with, or coupled to, elbow 66 of arm assembly 16. Forexample, exhaust member 52 may be coupled to an opening in an outersurface of elbow 66. Exhaust member 52 may include an opening 118extending though the member such that a gas passageway may be providedthat extends from the open portion of face mask 14 that may interfacewith the subject's face, through face mask 14, gasket 44, elbow 66, andout through the opening formed in exhaust member 52. Opening 118 inexhaust member 52 may be appropriately sized to allow a desired amountof gas flow through exhaust member 52 and/or to reduce or minimize noisecreated by gas flowing through exhaust member 52. In addition, in someembodiments, opening 118 may be oriented at an angle relative to generaldirection of gas flow between elbow 66 and face mask 14, which mayprovide various benefits. For example, the angle of opening 118 mayreduce and/or minimize the flow of exhaust gas incident upon anotherperson, such as the subject's bed partner. One embodiment of an exhaustmember 52 is illustrated and discussed in greater detail below withreference to FIGS. 19A-19B.

Base pad 60 may be generally operable to provide cushioning between maskbody 12 and the subject's head, such as, e.g., proximate the subject'sforehead. Base pad 60 may be formed from any suitable cushioningmaterial, and may be coupled to mask body 12 in any suitable manner. Forexample, in certain embodiments, base pad 60 may be coupled to mask body12 with hook and loop fasteners (e.g., Velcro™).

FIGS. 3A and 3B illustrate a system for securing an example embodimentof mask apparatus 10 onto a subject's head 150, according to oneembodiment of the disclosure. In particular, FIG. 3A illustrates maskapparatus 10 positioned in an untightened state on a subject's head 150,and FIG. 3B illustrates mask apparatus 10 positioned in a tightenedstate on the subject's head 150.

As shown in FIG. 3A, head strap 20 may be positioned around thesubject's head 150. Lever 96 is shown in an open, or untightened,position. As a result, head strap 20 may be relatively loose or laxaround the subject's head, such that mask apparatus 10 is not tightlysecured on the head 150 and may thus be relatively easily removed fromthe head 150. Lever 96 may be rotatable relative to mask body 12 aboutpivot points 76. In this particular embodiment, lever 96 is in the openposition when rotated downward toward face mask 14, as indicated byarrow 154. Rotating lever 96 downward toward the open position (from theclosed position shown in FIG. 4B) may shorten the distance between strapguides 94 on mask body 12 and the point(s) at which cord portion 92 ofhead strap 20 is coupled to lever 96. Thus, rotating lever 96 downwardtoward the open position may allow strap portion 90 of head strap 20 topull away from mask body 12, thus untightening head strap 20 around head150.

In contrast, as shown in FIG. 3B, lever 96 is shown in the closed, ortightened, position. As a result, head strap 20 may be relatively tightaround the subject's head, such that mask apparatus 10 may besubstantially secured on the head 150. In this embodiment, lever 96 isin the closed position when rotated upward toward the top of mask body12 and ball joint 50, as indicated by arrow 156. Rotating lever 96upward toward the closed position (from the open position shown in FIG.3A) may increase the distance between strap guides 94 on mask body 12and the point(s) at which cord portion 92 of head strap 20 is coupled tolever 96. Thus, rotating lever 96 upward toward the closed position maypull strap portion 90 toward mask body 12, which may tighten head strap20 around head 150. In other words, lever 96 may act as a cinch clamp orlever to tighten head strap 20 around head 150.

In some embodiments, tension within head strap 20 may act to hold lever96 in the closed position, as opposed to pulling lever 96 toward theopen position. For example, as shown in the embodiments of FIGS. 1-2,cord portion 92 of head strap 20 may pass by pivot points 76 on the sidecloser to mask body 12 and the subject's head 150. In other words, atthe point where cord portion 92 passes by pivot points 76, pivot points76 are located further from the subject's head 150 than cord portion 92.Thus, tension on cord portion 92 creates a moment on lever 96 in adirection toward mask body 12 and the subject's head 150, as indicatedby arrow 160 in FIG. 3B. Thus, the greater the tension in head strap 20,the greater the moment on lever 96 forcing lever 96 toward (or retaininglever 96 in) the closed position. Such configuration may thus reduce thelikelihood of lever 96 of moving to the open position without thesubject manually pulling lever 96 to the open position (at least whenmask apparatus 10 is being worn by a subject).

As shown in FIGS. 3A-3B, one or more adjustments may be made to maskapparatus 10 to position face mask 14 comfortably against the subject'sface and/or to reduce leaks between face mask 14 and the subject's face.For example, as discussed above, arm assembly 16 may be pivotallycoupled to mask body 12 at pivot points 76 such that arm assembly 16 maybe rotated toward and away from the subject's face to a desiredposition. Arm assembly 16 may be pivoted relative to mask body 12 byrotating threaded portion 82 of intermediate member 78, as discussedbelow with reference to FIG. 5. In addition, face mask 14 may be pivotedupward and/or downward relative to arm assembly 16 at pivot joint 86, asdesired by the subject. Also, head strap 20 may be adjusted to fit theparticular subject's head 150. For example, elongated side portions 102and/or elongated side portions 104 of strap portion 90 may be adjustedby un-securing and re-securing hook and loop fastener portions 110 atdifferent locations.

FIG. 4 illustrates a three-dimensional exploded view of mask apparatus10 (except for head strap 20), according to one particular embodiment ofthe disclosure. In this embodiment, mask apparatus 10 includes mask body12, face mask 14, arm assembly 16, head strap 20, gasket 44, ball joint50, base pad 60, intermediate member 78, and lever 96.

Mask body 12 may support arm assembly 16, ball joint 50, and/orintermediate member. Arm assembly may include arm member 72 and elbow66. Elbow 66 may include exhaust member 52, front elbow portion 200,slider seal 202, rear elbow portion 204, and clip 206. Exhaust member 52may be coupled to an opening in front elbow portion 200. Slider seal 202may generally be received within a first side of front elbow portion 200and such that slider seal 202 forms a seal between a rear surface 210 offront elbow portion 200 and a front surface 212 of rear elbow portion204. Slider seal 202 may thus reduce or eliminate gas leaking out frombetween front elbow portion 200 and rear elbow portion 204. Slider seal202 may be formed from any suitable sealing material, such as rubber ora flexible polymer, for example.

Rear elbow portion 204 may be coupled to front elbow portion 200 suchthat rear elbow portion 204 may slide relative to front elbow portion200. In some embodiments, rear surface 210 of front elbow portion 200and/or front surface 212 of rear elbow portion 204 are curved such thatrear elbow portion 204 may slide through an arc relative to front elbowportion 200. Thus, as rear elbow portion 204 slides through the arc,rear elbow portion 204 rotates relative to front elbow portion 200, suchthat face mask 14, which may be coupled (directly or indirectly) to rearelbow portion 204, rotates relative to arm member 72. Clip 206 may becoupled to rear elbow portion 204 in any suitable manner, such as byclipping onto rear elbow portion 204, for example.

As discussed above, face mask 14 may include relatively rigid baseportion 68 and relatively flexible, or pliable, cushion portion 70. Baseportion 68 may be coupled to cushion portion 70 in any suitable manner,such as by clips, adhesive, or fasteners, for example. In the embodimentshown in FIG. 4, base portion 68 includes a number of tabs 220 proximatean outer perimeter of base portion 68 and extending toward cushionportion 70. Tabs 220 may be received and locked into place in slots 222formed proximate an outer perimeter of cushion portion 70. Once lockedtogether, base portion 68 may be separated from cushion portion 70 bysqueezing cushion portion 70 proximate each of tab 220/slot 222interface such that each tab 220 is released from its corresponding slot222. In another embodiment, cushion portion 70 includes a number of tabsproximate an outer perimeter of cushion portion 70 and extending towardbase portion 68. Such tabs may be received and locked into place inslots formed proximate an outer perimeter of base portion 68. Similar tothe previous embodiment discussed above, once locked together, baseportion 68 may be separated from cushion portion 70 by squeezing cushionportion 70 proximate each of tab/slot interface such that each tab isreleased from its corresponding slot.

As discussed above, face mask 14 may be coupled to elbow 66 by gasket44. In this embodiment, gasket 44 may include a first lip 226 thatattaches to an opening 228 formed in base portion 68 of face mask 14,and a second lip 230 that may be held in place between (e.g., wedgedbetween) an outer surface of rear elbow portion 204 and an inner surfaceof clip 206, as shown in greater detail and discussed below withreference to FIG. 6.

As discussed above, both arm member 72 and lever 96 may be pivotallycoupled to mask body 12. In this embodiment, both arm member 72 andlever 96 are pivotally coupled to mask body 12 at the same pivot points76. Lever 96 may be substantially U-shaped and may include a pair oflever pegs 240, one on each side, that may be disposed within pivotholes 242 formed in side walls f of mask body 12. Thus, lever 96 maypivot relative to mask body 12 about pivot points 76. Each lever peg 240may have a hole 248 formed therein. Each hole 248 may or may not beconcentric with the outer surface of its respective lever peg 240. Armmember 72 may include a pair or arm pegs 250, one on each side, that maybe disposed within holes 248 formed in lever pegs 240. Thus, when lever96 and arm member 44 are assembled onto with mask body 12, arm pegs 250may rotate within holes 248 formed in lever pegs 240, which lever pegs240 may rotate within pivot holes 242 formed in mask body 12. In thismanner, both arm member 72 and lever 96 may be pivotally coupled to maskbody 12 at pivot points 76.

As used herein, the term “hole” may refer to any notch, slot, or otherindention of any shape or size and that may extend completely or onlypartially through the relevant element. Thus, for example, pivot holes242 may extend partially or completely through the thickness of sidewalls 244.

As discussed above, intermediate member 78 may include body portion 80and threaded portion 82 coupled (e.g., rotatably) to body portion 80. Asshown in FIG. 4, base portion may be U-shaped and may have a circularend that may be coupled (e.g., rotatably) with threaded portion 82.Threaded portion 82 may be ring-shaped and may have one or more threadsformed on an inner surface. Threaded portion 82 may also include grips260 on an outer surface that may provide the subject a better grip forrotating threaded portion 82 in order to pivot arm assembly 16. Grips260 may include any shape or configuration of the outer surface ofthreaded portion 82 and/or any material that may provide increasedfriction for facilitating the rotation of threaded portion 82.Intermediate member 78 may be disposed around arm member 72 such thatarm member extends through the ring-shaped openings in both body portion80 and threaded portion 82. The thread(s) formed on the inner surface ofthreaded portion 82 may interface with a series of threads 258 formed onthe outer surface of arm member 72.

Body portion 80 may include a pair of intermediate member pegs 262, oneon each side, each configured to be disposed in a notch 264 formed inside walls 244 of mask body 12. As used herein, the term “notch” mayrefer to any hole, notch, slot, or other indention of any shape or sizeand that may extend completely or only partially through the relevantelement. In certain embodiments, each notch 264 may be an elongatedopening appropriately sized and shaped to guide intermediate member pegs262 within and along such elongated openings. For example, each notch264 may have an elongated linear or curved shape. When mask apparatus 10is assembled, rotation of threaded portion 82 causes intermediate member78 to slide relative to arm member 72, which in turn causes intermediatemember pegs 262 slide within and along notches 264, which in turn forcesarm member 72 to pivot relative to mask body 12 about pivot points 76.Such interaction between intermediate member 78, arm member 72, and maskbody 12 in a particular embodiment of the disclosure is illustrated anddiscussed in greater detail below with reference to FIG. 5.

As discussed above, mask body 12 may also support ball joint 50, whichmay provide flexibility between portions of gas delivery pathway 28,such as between first gas delivery conduit 62 and second deliveryconduit 64 (e.g., see FIG. 2). Ball joint 50 may include any number ofcomponents arranged in any suitable manner to provide a flexible jointbetween portion of gas delivery pathway 28.

In the embodiment shown in FIG. 4, ball joint 50 includes a bottomhousing 270, a seal/spring 272, a top housing 274, and a ball 276. Ball276 may include a ball body 278 and a ball cap 280. Ball body 278 mayinclude a hollow cylinder and a hemispherical portion extending from afirst end of the cylinder. Ball cap 280 may comprise a hemisphericalportion having an opening configured to receive the hollow cylinder ofball body 278 and configured to abut the hemispherical portion of ballbody 278 such that the hemispherical portions of ball body 278 and ballcap 280 form a ball having a passage extending through the ball.However, in other embodiments, ball 276 may comprise a single orintegrated component.

Bottom housing 270 may attach to mask body 12. For example, as shown inFIG. 4, bottom housing 270 may include one or more tabs 282 that slideinto one or more notches 284 formed in mask body 12 such that bottomhousing 270 may be removably coupled to mask body 12. However, in otherembodiments, bottom housing 270 may be otherwise coupled to mask body12, or may not be coupled to mask body 12. Seal/spring 272 may bedisposed within and/or coupled to bottom housing 270 in any suitablemanner. In some embodiments, seal/spring 272 may include a flexible ringintegrated with, or coupled to, a seal ring. Ball 276 may be disposedagainst the seal ring of seal/spring 272 such that the seal ring mayprovide a first seal against the outer surface of ball 276. Top housing274 may then be positioned over ball 276 such that the cylindricalportion of ball body 278 extends through an opening in top housing 274.Top housing 274 may be coupled to bottom housing 270 in any suitablemanner in order to complete the assembly. For example, an edge of tophousing 274 may screw onto an edge of bottom housing 270. Onceassembled, an interior surface of top housing 274 acts as a second sealagainst the outer surface of ball 276. The assembly and operation of aparticular embodiment of a ball joint 50 are illustrated and discussedin greater detail below with reference to FIGS. 7A-7B.

FIG. 5 is a three-dimensional view of a portion of a mask assembly 10illustrating an arm adjustment system 40 according to one embodiment ofthe disclosure. In this particular embodiment, arm adjustment system 40may include an intermediate member 78 that may be manipulated oractuated to control the rotation of arm member 72 relative to mask body12 about pivot points 76. Intermediate member 78 may include bodyportion 80 and threaded portion 82 coupled (e.g., rotatably) to bodyportion 80. Body portion 80 may include a pair of intermediate memberpegs 262, each disposed in a notch 264 formed in a sidewall 244 of maskbody 12 such that intermediate member pegs 262 may slide within notches264 to allow body portion 80 to slide or otherwise move relative to maskbody 12.

Threaded portion 82 may be ring-shaped and may include one or morethreads 300 formed on an interior surface of the ring. These threads maybe threaded with one or more threads 258 formed on an outer surface ofarm member 72. As used herein, “threads” may refer to one or more ribsor notches extending partially or completely around a surface. In thisembodiment, threads 258 may comprise ribs extending a relatively shortportion of the distance around an outer surface of arm member 72. Aseries of threads 258 may be formed on opposing sides of arm member 72.In addition, a notch 304 may extend across and through each series ofthreads 258. Each notch 304 may be configured to guide a guide member306 formed on an interior surface of body portion 80 along arm member 72as intermediate member 78 slides along arm member 72, as discussedbelow. One embodiment of an arm member 72, including an exampleconfiguration of threads 258 and notches 304, is shown in FIGS. 15A-15B.In addition, one embodiment of a body portion 80 of an intermediatemember 78, including an example configuration of guide member 306, isshown in FIG. 16.

In order to actuate arm adjustment system 40, threaded portion 82 ofintermediate member 78 may be rotated relative to body portion 80. Asthreaded portion 82 is rotated, threads 258 on body portion 80 interactwith threads 258 on arm member 72, which causes intermediate member 78to slide along the length of arm member 72. In this embodiment, sincearm member 72 may be pinned to mask body 12 at pivot points 76, asintermediate member 78 slides along the length of arm member 72,intermediate member 78 may slide relative to mask body 12 andintermediate member pegs 262 may slide within notches 264. Thus, theorientation of notches 264 may control the direction that intermediatemember 78 slides relative to mask body 12.

In certain embodiments, notches 264 are elongated and extend in a firstdirection 310 having an angular offset from an axis 312 defined by aline extending through one of the pivot points 76 and the center pointof the notch 264 on the same the same side of mask body 12. For example,in this embodiment, notches 264 extend in a first direction 310 havingan angular offset in the direction of axis 314 (perpendicular to axis312) from axis 312. Axis 314 may thus extend generally perpendicular tothe surface of the subject's head (when mask assembly 10 is worn on thehead) at a point proximate pivot points 76. In certain embodiments,first direction 310 may be offset in the direction of the axis 314 fromaxis 312 by about 20 degrees to about 70 degrees. In a particularembodiment, first direction 310 may be offset in the direction of theaxis 314 from axis 312 by about 45 degrees.

Because notches 264 extend in a direction offset from axis 312, asintermediate member pegs 262 slide along notches 264 in direction 310,intermediate member 78 forces arm member 72 to rotate about pivot points76. In some embodiments, actuation of intermediate member 78 may rotatearm member 72 through an approximately 20 degree range of motion. Inother embodiments, arm member 72 may be rotated through a range ofmotion more or less than 20 degrees.

The rotation of arm member 72 may force intermediate member 78 to rotateabout intermediate member pegs 262. Thus, in this embodiment, rotatingthreaded portion 82 may cause intermediate member 78 to simultaneouslyslide and rotate relative to mask body 12. In addition, as intermediatemember 78 slides along arm member 72, each guide member 306 formed on aninterior surface of body portion 80 may slide within and along acorresponding notch 304 extending across and through threads 258. Guidemembers 306 and notches 304 may help maintain body portion 80 ofintermediate member 78 properly oriented with respect to arm member 72,which may facilitate the sliding of intermediate member 78 relative toarm member 72.

FIG. 6 is a three-dimensional view of a portion of a mask assembly 10illustrating the attachment of a face mask 14 to an arm assembly 16according to one embodiment of the disclosure. In this particularembodiment, such portion of mask assembly 10 includes a face maskadjustment system 42 generally configured for adjusting the orientationof face mask 14 relative to arm assembly 16, such as to provideincreased comfort to the subject and/or reduced leakage of gas betweenface mask 14 and the subject's face.

As shown in FIG. 6, elbow 66 may include front elbow portion 200, rearelbow portion 204, and clip 206. Front elbow portion 200 may include apair of guide members 340, one extending from each side of front elbowportion 200. Rear elbow portion 204 may include a pair of guide notches342, one formed in each side of rear elbow portion 204. Guide notches342 may be curved or arced. Rear elbow portion 204 may be coupled tofront elbow portion 200 such that guide members 340 are positioned inguide notches 342. In one embodiment, guide members 340 snap into guidenotches 342, which thereby couples rear elbow portion 204 to front elbowportion 200.

Rear elbow portion 204 may be coupled to front elbow portion 200 suchthat rear elbow portion 204 may slide relative to front elbow portion200. Since guide notches 342 may be curved or arced, as guide members340 slide along guide notches 342, rear elbow portion 204 may slidethrough an arc relative to front elbow portion 200. In addition, rearsurface 210 of front elbow portion 200 (see, e.g., FIG. 18B) and/orfront surface 212 of rear elbow portion 204 (see, e.g., FIG. 21A) may becurved to allow rear elbow portion 204 to slide through an arc relativeto front elbow portion 200.

As rear elbow portion 204 slides through an arc relative to front elbowportion 200, rear elbow portion 204 rotates relative to front elbowportion 200, such that face mask 14, which may be coupled to rear elbowportion 204 as discussed below, rotates relative to elbow 66 (and thusrelative to arm member 72).

Gasket 44 may be coupled to elbow 66 using clip 206. For example, secondlip 230 of gasket 44 may be secured between an outer surface 350 of rearelbow portion 204 and an inner surface 352 of clip 206. In oneembodiment, gasket 44 may be wedged between outer surface 350 and innersurface 352. However, gasket 44 may be otherwise coupled to rear elbowportion 204 and/or clip 206. Clip 206 may be coupled to rear elbowportion 204 in any suitable manner. For example, clip 206 may be clippedonto rear elbow portion 204 by clipping one or more clip tabs 354 formedon rear elbow portion 204 into one or more clip notches 356 formed inclip 206. Gasket 44 may be coupled to face mask 14 in any suitablemanner. For example, first lip 226 of gasket may attach to an opening228 formed in base portion 68 of face mask 14, such that a base flange358 of gasket 44 may be disposed against a front surface 359 of baseportion 68 to help form a seal between gasket 44 and base portion 68.

FIGS. 7A and 7B illustrate an example ball joint 50 according to oneembodiment of the disclosure. In particular, FIG. 7A is athree-dimensional exploded view of ball joint 50, and FIG. 7B is across-sectional view of ball joint 50 according to one embodiment.

As shown in FIGS. 7A and 7B, ball joint 50 may include bottom housing270, seal/spring 272, top housing 274, and a ball 276. Ball 276 mayinclude a ball body 278 and a ball cap 280. Ball body 278 may include ahollow cylinder portion 360 and a hemispherical portion 362 extendingfrom a first end of cylinder portion 360. Hollow cylinder portion 360may have a continuous cylindrical inner surface. Ball cap 280 may have ahemispherical shape having an opening configured to receive hollowcylinder portion 362 of ball body 278 and configured to abuthemispherical portion 362 of ball body 278 to form a ball having apassage extending through the ball.

Seal/spring 272 may include a flexible ring 366 integrated with, orcoupled to, a seal ring 368 in any suitable manner. For example, in oneembodiment, flexible ring 366 and seal ring 368 are molded together toform an integrated component. One example embodiment of a seal/spring272 assembly is shown in FIGS. 24A-24B. Flexible ring 366 may bedisposed within, or coupled to, bottom housing 270 in any suitablemanner such that seal ring 368 may be suspended from contacting bottomhousing 270. For example, flexible ring 366 may include a lip 370 thatmay rest against an edge 372 of bottom housing 270. Because ring 366 maybe flexible and may suspend seal ring 368 from contacting bottom housing270, seal ring 368 may move up and down relative to bottom housing 270,i.e., in the direction indicated by arrow 374. In some embodiments,bottom housing 270 may include one or more stops 378 configured to limitthe distance that seal ring 368 may move toward the bottom of bottomhousing 270. For example, bottom housing 270 may include three or morestops 378 located around an inner perimeter of bottom housing 270.

Seal ring 368 may be configured to interface with ball 276, as discussedbelow. Thus, seal ring 368 may have a desirable coefficient of friction,which may be lower than that of flexible ring 366. In other words,flexible ring 366 may be configured to provide a desired amount offlexibility and/or provide a desired amount of resiliency to resist sealring 368 being pushed toward the bottom of bottom housing 270, whereasseal ring 368 may be configured to provide a seal and/or a desired levelof friction against ball 276. In certain embodiments, flexible ring 366may be formed from an elastic material, such as a rubber or polymer, andseal ring 368 may be formed from a more rigid material, such as a morerigid polymer, for example.

As shown in FIG. 7B, ball 276 may be disposed against an inner surface,or rim, 371 of seal ring 368 such that ball 276 may rotate relative toseal ring 368. Top housing 274 may then be positioned over ball 276 suchthat hollow cylindrical portion 360 of ball body 278 extends through anopening 373 in top housing 274. Top housing 274 may be secured to bottomhousing 270 in any suitable manner in order to complete the assembly.For example, a thread or lip 375 of top housing 274 may screw onto athread or lip 376 of bottom housing 270.

When restrained by top housing 274, ball 276 forces seal ring 368downward toward bottom of bottom housing 270 due to the size of ball276. Flexible ring 366 flexes to allow such movement of seal ring 368,but provides resiliency to resist such flexing such that the resiliencyof flexible ring 366 may press seal ring 368 upwardly against ball 276,thus maintaining rim 371 of seal ring 368 in contact against ball 276.Such interface between rim 371 and ball 276 may act as a seal betweenrim 371 and ball 276, which may prevent or resist gas leakage from gasdelivery pathway 28 (particularly, from a portion of gas deliverypathway 28 defined by bottom housing 270). As discussed above, seal ring368 may be formed from a suitable material providing a desired level offriction against ball 276 in order to allow ball 276 to rotate with adesired level of freedom or resistance.

In addition, the resiliency of flexible ring 366 may force ball 276upward against a rim 380 associated with top housing 274. In thisembodiment, rim 380 may be defined by top housing 274. In otherembodiments, rim 380 may be provided by a separate component coupled toor otherwise associated with top housing 274.

Such interface between rim 380 and ball 276 may act as a seal betweenrim 380 and ball 276, which may prevent or resist gas leakage from gasdelivery pathway 28. For example, the seal between rim 380 and ball 276may prevent or resist the leakage of gas from a volume defined byseal/spring 272 and top housing 274. Thus, this seal may act as a secondseal to prevent or resist the leakage of gas from gas delivery pathway28. As discussed above regarding seal ring 368, top housing may beformed from a material having a coefficient of friction that may providea desired level of friction against ball 276, in order to allow ball 276to rotate with a desired level of freedom or resistance.

Ball joint 50 may be configured to provide flexibility between separatecomponents of gas delivery pathway 28. For example, hollow cylinderportion 360 of ball body 278 may be configured to be coupled to a firstportion of gas delivery pathway 28 (such as a first gas deliver conduit62, as shown in the embodiment of FIGS. 3A-3B), and a hollow cylinderportion 386 of bottom housing 270 may be configured to be coupled to asecond portion of gas delivery pathway 28 (such as a second gas deliverconduit 64, as shown in the embodiment of FIGS. 3A-3B). Such portions ofgas delivery pathway 28 (e.g., gas deliver conduits 62 and 64) may becoupled to hollow cylinder portions 360 and 386 in any suitable manner.For example, the portions of gas delivery pathway 28 may slide over orwithin hollow cylinder portions 360 and 386, respectively, in order toform a relatively secure connection between such components. As shown inFIG. 7B, ball 276 may rotate in any number of directions relative tohousing 270, 274 in order to provide flexibility between separatecomponents of gas delivery pathway 28 (e.g., gas deliver conduits 62 and64).

In addition, as shown in FIG. 7B, hollow cylinder portion 360 may have acontinuous cylindrical inner surface, and the seam or joint between ballbody 278 and ball cop 280 may be located external to the gas flowpassageway. Thus, there are no seams or joints between the components ofball 276 in the gas flow passageway, which may further reduce theleakage of gas from gas delivery pathway 28. Such configuration, as wellas the multiple seals provided between ball 276 and adjacent componentsof ball joint 50, may prevent or resist gas from leaking or escaping,which may provide various advantages, such as reducing gas pressurelosses and/or reducing or eliminating noise caused by gas escaping fromthe assembly, for example.

FIGS. 8A-8D illustrate an example configuration of a gasket 44,according to one embodiment of the disclosure. In particular, FIG. 8A isa three-dimensional view taken generally from the front of gasket 44,FIG. 8B is a three-dimensional view taken generally from the rear ofgasket 44, FIG. 8C is a front view of gasket 44, and FIG. 8D is across-sectional view of gasket 44 taken along lines A-A shown in FIG.8C.

In this embodiment, gasket 44 may include a first lip 226, a base flange358, a skirt 402, and a second lip 230. Skirt 402 may generally couplebase flange 358 with second lip 230. Base flange 358 may be configuredto interface with a front surface 359 of base portion 68 of face mask 14proximate an opening 228 formed in base portion 68 (see, e.g., FIG. 6).Base flange 358 may have any suitable shape. For example, base flange358 may be shaped to correspond with the shape of opening 228 formed inbase portion 68. In this particular embodiment, base flange 358 has agenerally triangular shape with rounded corners. A first index 404 ofthe generally triangular shape generally points in a longitudinaldirection 405 (i.e., pointing upward when the subject's head is in anupright position), while the other two indexes 406 and 408 of thegenerally triangular shape generally point downwardly and laterally.

First lip 226 may be formed proximate base flange 358 and may beconfigured to attach gasket 44 to base portion 68 of face mask 14. Forexample, first lip 226 may be malleably inserted into opening 228 formedin base portion 68 such that first lip 226 grips an inner ridge of baseportion 68 proximate opening 228. First lip 226 may have any suitableshape and/or configuration for attaching gasket 44 to base portion 68.However, in other embodiments, gasket 44 may be otherwise coupled tobase portion 68, such as using an adhesive, clips, taps, or one or morefasteners, for example.

Second lip 230 may be configured for coupling gasket 44 to a mask arm orarm assembly 16, such as discussed above regarding the embodiment shownin FIG. 6, for example. In some embodiments, second lip 230 may beconfigured to be wedged or otherwise held between two or more componentsof a mask arm assembly 16. In other embodiments, second lip 230 may beconfigured to grip a surface of a component of mask arm assembly 16,such as in the manner described above with respect to first lip 226gripping an inner ridge of opening 228 in base portion 68, for example.However, in other embodiments, gasket 44 may be otherwise coupled to amask arm assembly 16, such as using an adhesive, clips, taps, or one ormore fasteners, for example.

Second lip 230 may have any suitable shape and/or configuration forattaching gasket 44 to a mask arm or arm assembly 16. In thisembodiment, second lip 230 has a generally rectangular shape withrounded corners. Skirt 402 may be configured to couple first lip 226 andsecond lip 230. In this embodiment, skirt 402 transitions between thegenerally triangular base flange 358 and the generally rectangularsecond lip 230. In some embodiments, such as shown in FIGS. 8A-8D, skirt402 comprises a generally direct and smooth transition between baseflange 358 and second lip 230, which transition may be free of bellowsand/or folds. In other embodiments, skirt 402 may include one or morebellows and/or folds.

Skirt 402 may be flexible to allow face mask 14 to flex in one or moredirections relative to arm assembly 16. In some embodiments, skirt 402may be flexible, but sufficiently rigid to substantially hold face mask14 in constant position relative to arm apparatus 16 when face mask 14is free from external (e.g., subject-induced) forces. Thus, gasket 44may be formed from one or more materials suitable to provide suchrigidity. For example, in certain embodiments, gasket 44 may be formedfrom a material having a durometer hardness of greater than 45 shore A,such as a suitable rubber, silicone, or polymer material. In particularembodiments, gasket 44 may be formed from a material having a durometerhardness of approximately 60 shore A, such as a suitable rubber,silicone, or polymer material. In a particular embodiment, gasket 44 maybe formed from a silicone having a durometer hardness of approximately60±5 shore A.

In certain embodiments, gasket 44 may include one or more portions orreinforcing members configured to control the flexibility of gasket 44and/or to prevent or resist skirt 402 from collapsing or otherwisebecoming undesirably deformed during use. In the embodiment shown inFIGS. 8A-8D, gasket 44 includes a reinforcing member 414 configured toprevent or resist skirt 402 from collapsing and/or to control theflexibility of face mask 14 relative to arm assembly 16 in the directionindicated by arrow 41 & in FIG. 8A (or in other words, to restrict themovement of a lower edge 420 of second lip 230 relative to base flange358 in the direction indicated by arrow 422 in FIG. 8D). Reinforcingmember 414 may be distinct from or integrally formed with gasket 44. Inthis particular embodiment, reinforcing member 414 comprises a portionof skirt 402 formed with a greater thickness than other portions ofskirt 402. For example, skirt 402 may have a substantially uniformthickness extending around the perimeter of skirt 402 excludingreinforcing member 414, and reinforcing member 414 has a substantiallygreater thickness than the remainder of skirt 402. In some embodiments,the thickness of reinforcing member 414 may be approximately two to tentimes as great as the thickness of remaining portions of skirt 402. In aparticular embodiment, the thickness of reinforcing member 414 may beapproximately five times as great as the thickness of remaining portionsof skirt 402.

In some embodiments, reinforcing member 414 may control the flexibilityof face mask 14 relative to arm assembly 16 in the longitudinaldirection indicated by arrow 418 in FIG. 8B, such that face mask 14 maybe more easily rotated relative to arm apparatus 14 in a lateraldirection indicated by arrow 424 in FIGS. 8A-8B than in the longitudinaldirection indicated by arrow 418. Such control of flexibility in thelongitudinal direction may reduce the likelihood of face mask 14becoming disoriented from the subject's face, which may advantageouslyreduce the likelihood of gas leakage between face mask 14 and thesubject's face.

FIG. 9 illustrates an example configuration of a mask body 12, accordingto one embodiment of the disclosure. In this embodiment, mask body 12may include a pair of sidewalls 244 extending generally perpendicularfrom a generally flat portion. A pivot hole 242 and a notch 264 may beformed in each sidewall 244. Holes 248 may be configured for receivinglever pegs 240 and/or arm pegs 250 such that holes 248 define pivotpoints 76 about with lever 96 and/or arm member 72 may rotate. Notch 264may be configured for receiving and/or guiding intermediate member pegs262 as intermediate member 78 slides relative to mask body 12.

Mask body 12 may also include one or more strap guides 94 configured toguide and/or retain head strap 20. For example, in some embodiments inwhich head strap 20 includes a cord portion 92, strap guides 94configured to guide and/or retain a cord portion 92. In addition, asshown in FIG. 9, strap guides 94 may be configured such that head strap20 (e.g., cord portion 92) may be removed from strap guides 94 bymanipulating head strap 20 (e.g., cord portion 92).

Mask body 12 may also include one or more notches 284 for receivingand/or securing ball joint 50 to mask body 12. For example, notches 284may receive one or more tabs 282 coupled to a component of ball joint50, such that ball joint 50 may be secured against mask body 12. Inother embodiments, mask body 12 may include any other suitable notchesor elements suitable to secure ball joint 50 to mask body 12.

Mask body 12 may also include an eyelet 106 through which a portion 104of a head strap 20 may be routed to help secure mask body 12 against asubject's head.

Mask body 12 may be formed from any suitable material. In someembodiments, mask body 12 may be formed from a suitable plastic orpolymer. In a particular embodiment, mask body 12 may be formed from arelatively rigid polycarbonate.

FIG. 10 illustrates an example configuration of a base pad 60, accordingto one embodiment of the disclosure. Base pad 60 may be configured toprovide padding or cushioning between mask body 12 and a subject's head.Base pad 60 may have any suitable shape, which may correspond with ashape of mask body 12. Base pad 60 may be coupled to mask body 12 in anysuitable manner. For example, in certain embodiments, base pad 60 may becoupled to a hook and loop fastener sheet 450 (see FIG. 11) secured tomask body 12.

Base pad 60 may be formed from any suitable material. In someembodiments, base pad 60 may be formed from a suitable flexible orcushioning material. In particular embodiments, base pad 60 may beformed from neoprene or breathoprene.

FIG. 11 illustrates an example configuration of a hook and loop fastenersheet 450, according to one embodiment of the disclosure. Sheet 450 maybe configured for attaching base pad 60 to mask body 12 in any suitablemanner. Sheet 450 may include one or more components. In this example,sheet 450 includes a pair of symmetrical halves. In some embodiments,one side of sheet 450 may be coupled to mask body 12 by adhesive, andthe opposite side of sheet 450 may include hook and loop fasteners(e.g., Velcro™) to which base pad 60 may attach.

FIG. 12 illustrates an example configuration of a strap portion 90 of ahead strap 20, according to one embodiment of the disclosure. Strapportion 90 may be generally configured to secure mask assembly 10 onto asubject's head. In some embodiments, strap portion 90 may be configuredto cooperate with one or more other components of head strap 20, such asa cord portion 92, in order to secure mask assembly 10 onto thesubject's head. In the embodiment shown in FIG. 12, strap portion 90 mayinclude a pair of elongated side portions 102 and an elongated topportion 104. Each elongated portion 102, 104 may include a hook and loopfasteners (e.g., Velcro™) portion 110 and may be routed through eyelets(e.g., eyelets 100 and 106) in order to secure mask body 12 against thesubjects head, such as discussed above regarding the embodiment shown inFIGS. 3A-3B, for example.

Strap portion 90 may be formed from any suitable material. In someembodiments, strap portion 90 may be formed from a suitable flexible orcushioning material. In other embodiments, strap portion 90 may beformed from a generally non-flexible material. In particularembodiments, strap portion 90 may be formed from neoprene orbreathoprene.

FIGS. 13A and 13B illustrate an example configuration of a cord portion92 of a head strap 20, according to one embodiment of the disclosure.Cord portion 92 may be generally configured to secure mask assembly 10onto a subject's head. In some embodiments, cord portion 92 may beconfigured to cooperate with one or more other components of head strap20, such as a strap portion 90, in order to secure mask assembly 10 ontothe subject's head. In the embodiment shown in FIGS. 13A and 13B, cordportion 92 may include a cord 460 and an eyelet 100 attached at each endof cord 460. Cord 460 may be formed from any suitable material. In someembodiments, cord 460 may be formed from a flexible material, such aselastic, for example. In other embodiments, cord 460 may be formed froma generally non-flexible material.

Eyelets 100 may be formed from any suitable material, such as a plasticor polymer, for example, and may be coupled to cord 460 in any suitablemanner, such as by insert molding, for example. Each eyelets 100 mayinclude an opening 462 through which elongated side portions 102 ofstrap portion 90 may be routed, such as described herein.

FIG. 14 illustrates an example configuration of a lever 96, according toone embodiment of the disclosure. Lever 96 may be generally configuredfor adjusting head strap 20 around a subject's head, such as to tightenor loosen head strap 20 around the subject's head, for example. Forexample, lever 96 may operate as a cinch clamp to control the tightnessof head strap 20 around the subject's head. In this embodiment, lever 96may include a pair of lever pegs 240 that may be inserted into pivotholes 242 formed in mask body 12 such that lever 96 may rotate aboutlever pegs 240 relative to mask body 12. A hole 248 may be formed ineach lever peg 240 and configured to receive an arm peg 250 formed onarm member 72, such that arm member 72 may rotate about the same pivotpoints as lever 96. Lever 96 may also include one or more strapretention members 114 that may be configured to hold or retain cordportion 92 of head strap 20.

Lever 96 may be formed from any suitable material. In some embodiments,lever 96 may be formed from a suitable plastic or polymer. In aparticular embodiment, lever 96 may be formed from a relatively rigidpolycarbonate.

FIGS. 15A and 15B illustrate an example configuration of an arm member72, according to one embodiment of the disclosure. In particular, FIG.8A is a three-dimensional view of arm member 72, and FIG. 15B is a sideview of arm member 72. Arm member 72 may be generally configured forsupporting face mask 14.

In this embodiment, arm member 72 may include a pair of arm pegs 250that may be inserted into holes 248 formed in lever pegs 240, which maybe inserted into pivot holes 242 formed in mask body 12, such that armmember 72 may rotate relative to mask body 12. Alternatively, arm pegs250 may be inserted directly into pivot holes 242 formed in mask body 12such that arm member 72 may rotate relative to mask body 12.

In addition, one or more threads 258 may be formed on an outer surfaceof arm member 72 which may be configured to interact with threadedportion 82 of intermediate member 78 in order to rotate arm member 72 asdesired. In this embodiment, threads 258 may comprise ribs extending arelatively short distance around an outer surface of arm member 72. Aseries of threads 258 may be formed on opposing sides of arm member 72.In addition, in this embodiment, a notch 304 may extend across andthrough each series of threads 258. Each notch 304 may be configured toguide a guide member 306 formed on an interior surface of body portion80 of intermediate member 78 along arm member 72.

Arm member 72 may also include one or more notches 470 configured toreceive one or more elbow pegs 472 formed in elbow 66 such that elbow 66may be removably coupled to arm member 72. For example, in thisembodiment, notches 470 are configured such that elbow pegs 472 may beinserted upward into notches 470 and elbow 66 may then be rotated inorder to secure elbow pegs 472 with notches 470.

Arm member 72 may be formed from any suitable material. In someembodiments, arm member 72 may be formed from a suitable plastic orpolymer. In a particular embodiment, arm member 72 may be formed from arelatively rigid polycarbonate.

FIG. 16 illustrates an example configuration of a body portion 80 of anintermediate member 78, according to one embodiment of the disclosure.Body portion 80 may be generally configured to cooperate with threadedportion 82, arm member 72, and mask body 12 in order to adjust thepositioning of arm member 72.

In this embodiment, body portion 80 may be generally U-shaped. Inaddition, body portion 80 may include a ring-shaped portion 480configured to be coupled (e.g., rotatably) to threaded portion 82 in anysuitable manner. For example, body portion 80 may include one or moretabs 482 extending from an inner perimeter of ring-shaped portion 480.Tabs 482 may be configured to slide within a groove 490 extending aroundan outer perimeter of threaded portion 82 such that threaded portion 82may be coupled (e.g., rotatably) to body portion 80. Body portion 80 mayalso include a pair of intermediate member pegs 262 configured to beinserted into and/or guided by notches 264 formed in sidewalls 244 ofmask body 12.

Body portion 80 may be formed from any suitable material. In someembodiments, body portion 80 may be formed from a suitable plastic orpolymer. In a particular embodiment, body portion 80 may be formed froma relatively rigid polycarbonate.

FIG. 17 illustrates an example configuration of a threaded portion 82 ofan intermediate member 78, according to one embodiment of thedisclosure. Threaded portion 82 may be generally configured to cooperatewith body portion 80, arm member 72, and mask body 12 in order to adjustthe positioning of arm member 72. Threaded portion 82 may be ring-shapedand may include one or more threads 300 formed on an inner surface ofthe ring. Threads may interact with one or more series of threads 258formed on an outer surface of arm member 72.

Threaded portion 82 may also include a groove 490 extending around anouter perimeter of threaded portion 82. Groove 490 may be configured toreceive one or more tabs 482 of body portion 80 such that threadedportion 82 may be coupled (e.g., rotatably) to body portion 80. Threadedportion 82 may also include grips 260 on an outer surface that mayprovide the subject a better grip for rotating threaded portion 82 inorder to pivot arm assembly 16.

Body portion 80 may be formed from any suitable material. In someembodiments, body portion 80 may be formed from a suitable plastic orpolymer. In addition, body portion 80 may be formed from a materialhaving a particular (e.g., relatively low) coefficient of friction inorder to provide a desired (e.g., relatively low) amount of frictionbetween threads 300 and threads 258 on arm member 72. For example, inparticular embodiments, body portion 80 may be formed from apolybutylene terephthalate (PBT) polymer, for example.

FIGS. 18A and 18B illustrate an example configuration of a front elbowportion 200, according to one embodiment of the disclosure. Inparticular, FIG. 18A is a three-dimensional view taken from the front offront elbow portion 200, and FIG. 18B is a three-dimensional view takenfrom the rear of front elbow portion 200. Front elbow portion 200 may begenerally configured for facilitating the coupling of face mask 14 toarm member 72. In addition, front elbow portion 200 may be generallyconfigured to interact with rear elbow portion 204 to form a pivot joint86 allowing face mask 14 to rotate in a generally longitudinaldirection.

Front elbow portion 200 may include one or more elbow pegs 472configured to be received into one or more notches 470 formed in armmember 72 in order to removably couple front elbow portion 200 to armmember 72. For example, in this embodiment, elbow pegs 472 may beinserted upward into notches 470 and front elbow portion 200 may then berotated in order to secure elbow pegs 472 with notches 470.

Front elbow portion 200 may include tabs 340 configured to be insertedinto curved notches 342 formed in rear elbow portion 204, such that rearelbow portion 204 may slide through an arc relative to front elbowportion 200 in order to rotate face mask 14 in a generally longitudinaldirection. In addition, a rear surface 210 of front elbow portion 200may have a curved shape configured to cooperate with a curved frontsurface of rear elbow portion 204 as rear elbow portion 204 slidesthrough an arc relative to front elbow portion 200. Front elbow portion200 may also be configured to receive a slider seal 202 that may providean interface between front elbow portion 200 and rear elbow portion 204as elbow portion 204 slides relative to front elbow portion 200. Sliderseal 202 may generally be operable to reduce the amount of frictionbetween front elbow portion 200 and rear elbow portion 204.

Front elbow portion 200 may also include an opening 500 configured toreceive an exhaust member 52 allowing gas to escape from elbow 66 to thesurrounding environment. Front elbow portion 200 may be formed from anysuitable material. In some embodiments, front elbow portion 200 may beformed from a suitable plastic or polymer. In a particular embodiment,front elbow portion 200 may be formed from a relatively rigidpolycarbonate.

FIGS. 19A and 19B illustrate an example configuration of an exhaustmember 52, according to one embodiment of the disclosure. In particular,FIG. 19A is a three-dimensional view of exhaust member 52, and FIG. 19Bis a cross-sectional side view of exhaust member 52. Exhaust member 52may generally be configured to allow gas exhaled by the subject (e.g.,CO₂) to escape from mask apparatus 10 to the surrounding environment.Exhaust member 52 may be integrated with, or coupled to, elbow 66 of armassembly 16 in any suitable manner. For example, exhaust member 52 mayinclude a flexible lip 510 configured to be inserted into opening 500 infront elbow portion 200 to secure exhaust member 52 to front elbowportion 200.

Exhaust member 52 may include one or more gas passageways 520 configuredto allow gas (e.g., exhaust gas exhaled by a subject) to flow out frommask assembly 10 and into the surrounding environment. For example, insome embodiments, a gas exhaust pathway may allow gas to flow from thesubject, through face mask 14, through gasket 44, through elbow 66,through one or more gas passageways 520, and into the surroundingenvironment. In particular embodiments, such as the embodiment shown inFIGS. 19A-19B, mask apparatus 10 may include a single gas passageway520. In other embodiments, mask apparatus 10 may include multiple gaspassageways 520.

As shown in FIG. 19B, the single gas passageway 520 may extend from afirst opening 118 formed in a first side of exhaust member 52 to asecond opening 522 formed in a second side of exhaust member 52. In someembodiments, the size and/or shape of gas passageway 520 may beconfigured to (a) allow a desired amount of gas flow through gaspassageway 520 and/or (b) to reduce or minimize the amount of noisecreated by gas flowing through gas passageway 520.

For example, a diameter 512 and/or a cross-sectional area A₁₁₈ of firstopening 118 may be appropriately sized to allow a desired amount of gasflow through gas passageway 520 and/or to reduce or minimize the amountof noise created by gas flowing through gas passageway 520. In someembodiments, diameter 512 may be about 0.10 inches to about 0.20 inches,and cross-sectional area A₁₁₈ may be about 0.008 square inches to about0.031 square inches. In particular embodiments, diameter 512 may beabout 0.125 inches to about 0.175 inches, and cross-sectional area A₁₁₈may be about 0.012 square inches to about 0.024 square inches. In oneembodiment, diameter 512 may be about 0.146 inches, and cross-sectionalarea A₁₁₈ may be about 0.017 square inches.

In addition, in some embodiments, a cross-sectional area A₅₂₂ of secondopening 522 may have a different shape and/or size than cross-sectionalarea A₁₁₈ of first opening 118. For example, cross-sectional area A₅₂₂of second opening 522 may be substantially greater than across-sectional area A₁₁₈ of first opening 118. In certain embodiments,cross-sectional area A₅₂₂ may be at least twice as great ascross-sectional area A₁₁₈. In one particular embodiment, cross-sectionalarea A₅₂₂ may be more than three times as great as cross-sectional areaA₁₁₈. In addition, in some embodiments, cross-sectional area A₁₁₈ mayhave a substantially circular shape and cross-sectional area A₅₂₂ mayhave a substantially elongated, or oval, shape.

In some embodiments, e.g., the embodiment shown in FIGS. 19A-19B, gaspassageway 520 may include a substantially cylindrical portion 526 and atransition portion 528 that may transition between the cross-section ofcylindrical portion 526 and the cross-section of second opening 522. Insome embodiments, a length (or depth) of cylindrical portion 526 may beappropriately sized to reduce or minimize the amount of noise created bygas flowing through gas passageway 520.

In addition, in some embodiments, gas passageway 520 or a portion of gaspassageway 520 (e.g., cylindrical portion 526) may be oriented at aparticular angle 514 relative to a generally horizontal axis 530 toprovide one or more desired performance characteristics. For example,angle 514 may be selected to reduce or minimize the flow of exhaust gasincident upon another person, such as the subject's bed partner and/orto reduce or minimize the amount of noise created by gas flowing throughgas passageway 520. For example, angle 514 may be greater than 35degrees. In some embodiments, angle 514 may be about 50 degrees to about80 degrees. In a particular embodiment, angle 514 may be 65±5 degrees.Generally horizontal axis 530 be defined as an axis perpendicular to agenerally vertical axis 532 defined by the rear edges of member 52(e.g., lip 510).

Exhaust member 52 may be formed from any suitable material. Exhaustmember 52 may be formed from a flexible material, such as a rubber,silicone or polymer, for example. In some embodiments, exhaust member 52may be formed from a material having a durometer hardness ofapproximately 45±10 shore A. In particular embodiments, exhaust member52 may be formed from a thermoplastic elastomer, such as Santoprene™281-45MED, for example.

FIG. 20 illustrates an example configuration of a slider seal 202,according to one embodiment of the disclosure. Slider seal 202 maygenerally be configured to provide an interface between front elbowportion 200 and rear elbow portion 204 to provide a desired (e.g.,relatively low) level of friction between rear elbow portion 204 andfront elbow portion 200 as rear elbow portion 204 slides relative tofront elbow portion 200. Slider seal 202 may be received in an openingformed in front elbow portion 200.

Slider seal 202 may be formed from any suitable material. In someembodiments, slider seal 202 may be formed from a material having arelatively low coefficient of friction, such as a silicon or polymermaterial. In a particular embodiment, slider seal 202 may be formed froma silicone having a durometer hardness of approximately 60±5 shore A.

FIGS. 21A and 21B illustrate an example configuration of a rear elbowportion 204, according to one embodiment of the disclosure. Inparticular, FIG. 21A is a three-dimensional view taken from the front ofrear elbow portion 204, and FIG. 21B is a three-dimensional view takenfrom the rear of rear elbow portion 204. Rear elbow portion 204 may begenerally configured to interact with front elbow portion 200 to form apivot joint 86 allowing face mask 14 to rotate in a generallylongitudinal direction.

Rear elbow portion 204 may include notches 342 configured to receivetabs 340 formed on front elbow portion 200 in order to secure frontelbow portion 200 to rear elbow portion 204. In some embodiments,notches 342 are curved such that rear elbow portion 204 may slidethrough an arc relative to front elbow portion 200 in order to rotateface mask 14 in a generally longitudinal direction. In addition, a frontsurface 212 of rear elbow portion 204 may have a curved shape configuredto cooperate with a curved rear surface of front elbow portion 200 asrear elbow portion 204 slides through an arc relative to front elbowportion 200. Rear elbow portion 204 may also include tabs 354 configuredto be inserted into notches 356 formed in clip 206, such that clip 206may be secured to rear elbow portion 204.

Rear elbow portion 204 may be formed from any suitable material. In someembodiments, rear elbow portion 204 may be formed from a suitableplastic or polymer. In a particular embodiment, rear elbow portion 204may be formed from a relatively rigid polycarbonate.

FIG. 22 illustrates an example configuration of a clip 206, according toone embodiment of the disclosure. Clip 206 may be generally configuredto secure gasket 44 to elbow 66. For example, second lip 230 of gasket44 may be held (e.g., wedged) between an internal surface 352 of clip206 and an external surface 350 of rear elbow portion 204. Clip 206 mayalso include notches 356 into which tabs 354 formed on rear elbowportion 204 may be inserted in order to secure clip 206 to rear elbowportion 204.

Clip 206 may be formed from any suitable material. In some embodiments,clip 206 may be formed from a suitable plastic or polymer. In aparticular embodiment, clip 206 may be formed from a relatively rigidpolycarbonate.

FIG. 23 illustrates an example configuration of a bottom housing 270 ofa ball joint 50, according to one embodiment of the disclosure. Bottomhousing 270 may generally be configured to cooperate with a top housing274 to provide a housing for a ball 276 of ball joint 50. Bottom housing270 may include a cylindrical portion 386 configured to be coupled to acomponent of a gas delivery pathway 28, such as a length of flexibletubing, for example.

Bottom housing 270 may also include a thread or lip 376 that mayinteract with a thread or lip 375 of top housing 274 to screw orotherwise secure top housing 274 onto bottom housing 270. In addition,bottom housing 270 may include one or more stops 378 configured to limitthe amount of flexing of a seal ring 368 disposed within bottom housing270. In a particular embodiment, bottom housing 270 may include threestops 378 located around an inner perimeter of bottom housing 270.Bottom housing 270 may also include one or more tabs 282 that may slideinto one or more notches 284 formed in mask body 12 in order toremovably secure bottom housing 270 to mask body 12.

Bottom housing 270 may be formed from any suitable material. In someembodiments, bottom housing 270 may be formed from a suitable plastic orpolymer. In a particular embodiment, bottom housing 270 may be formedfrom a relatively rigid polycarbonate.

FIGS. 24A and 24B illustrate an example configuration of a seal/spring272, according to one embodiment of the disclosure. In particular, FIG.24A is a three-dimensional exploded view of seal/spring 272, and FIG.24B is a cross-sectional side view of seal/spring 272. Seal/spring 272may be generally configured to provide a seal against ball 276 toprevent or resist gas from leaking out of ball joint 50.

Seal/spring 272 may include a flexible ring 366 integrated with, orcoupled to, a seal ring 368 in any suitable manner. For example, in oneembodiment, flexible ring 366 and seal ring 368 are molded together toform an integrated component. Flexible ring 366 may be configured to bereceived within, or coupled to, bottom housing 270 in any suitablemanner such that seal ring 368 may be suspended from contacting bottomhousing 270. Flexible ring 366 may include a lip 370 that may restagainst an edge of bottom housing 270.

Seal ring 368 may be configured to receive ball 276 such that ball 276may rotate relative to seal ring 368. Seal ring 368 may include acircular rim 371 that may provide a seal against the outer surface ofball 276. Seal ring 368 may be formed from a suitable material providinga desired level of friction between rim 371 and ball 276 in order toallow ball 276 to rotate with a desired level of freedom or resistance.In certain embodiments, flexible ring 366 may be formed from a flexibleand/or resilient material, such as a rubber, silicone, or polymer, andseal ring 368 may be formed from a more rigid material having a lowercoefficient of friction than flexible ring 366. In particularembodiments, flexible ring 366 may be formed from a silicone having adurometer hardness of approximately 60±5 shore A, and seal ring 368 maybe formed from a polybutylene terephthalate (PBT) polymer, for example.

FIGS. 25A and 25B illustrate an example configuration of a top housing274, according to one embodiment of the disclosure. In particular, FIG.25A is a three-dimensional view taken from the top of top housing 274,and FIG. 25B is a three-dimensional view taken from the top of tophousing 274. Top housing 274 may be generally configured to cooperatewith a bottom housing 270 to provide a housing for a ball 276 of balljoint 50.

Top housing 274 may include one or more threads or lips 375 that mayinteract with a thread or lip 376 of bottom housing 270 to screw orotherwise secure top housing 274 onto bottom housing 270. Top housing274 may include a circular rim 380 that may provide a seal against theouter surface of ball 276. Top housing 274 may be formed from a suitablematerial providing a desired level of friction between rim 380 and ball276 in order to allow ball 276 to rotate with a desired level of freedomor resistance. In some embodiments, top housing 274 may be formed from asuitable plastic or polymer. In a particular embodiment, top housing 274may be formed from a relatively rigid polycarbonate.

FIGS. 26A and 26B illustrate an example configuration of a ball body278, according to one embodiment of the disclosure. In particular, FIG.26A is a three-dimensional of ball body 278, and FIG. 26B is across-sectional side view of ball body 278. FIGS. 27A and 27B illustratean example configuration of a ball cap 280, according to one embodimentof the disclosure. In particular, FIG. 27A is a three-dimensional ofball cap 280, and FIG. 27B is a cross-sectional side view of ball cap280.

Ball body 278 and ball cap 280 may combine to form ball 276. Ball body278 may include a hollow cylindrical portion 360 and a hemisphericalportion 362 extending from a first end of hollow cylindrical portion360. Ball body 278 and/or ball cap 280 may be formed from a materialhaving a particular (e.g., relatively low) coefficient of friction inorder to provide a desired (e.g., relatively low) amount of frictionbetween ball 276 and seal ring 368 and/or between ball 276 and tophousing 274. For example, in particular embodiments, Ball body 278and/or ball cap 280 may be formed from a polybutylene terephthalate(PBT) polymer, for example.

Although the disclosed embodiments have been described in detail, itshould be understood that various changes, substitutions and alterationscan be made herein without departing from the spirit and scope of thedisclosure as illustrated by the following claims. For example, itshould be understood that in various embodiments, gas delivery maskapparatus 10 may include any combination of one, some or all of thevarious components and/or features discussed above and/or any one ormore additional components and/or features.

1. A system for adjusting a gas delivery mask, the system comprising: abase; an arm pivotally coupled to the base, the arm including a firstthreaded portion; and an intermediate member slidably coupled to boththe base and the arm, the intermediate member including a secondthreaded portion coupled to the first threaded portion, wherein rotationof the second threaded portion relative to the first threaded portionslides the intermediate member along the arm and relative to the basesuch that the arm pivots relative to the base.
 2. A system according toclaim 1, wherein the intermediate member comprises a sleeve disposedaround the arm.
 3. A system according to claim 1, wherein: the baseincludes an elongated notch; the intermediate member includes a pegslidably coupled to the elongated notch; and rotation of the secondthreaded portion relative to the first threaded portion slides the pegalong the elongated notch.
 4. A system according to claim 1, wherein:the base includes an elongated notch; the intermediate member includes abody portion including a peg slidably coupled to the elongated notch;and the second threaded portion is rotatably coupled to the bodyportion.
 5. A system according to claim 1, wherein: the intermediatemember includes an elongated notch; and the base includes a peg slidablycoupled to the elongated notch.
 6. A system according to claim 1,wherein rotation of the second threaded portion relative to the firstthreaded portion slides the intermediate member along the arm in a firstdirection and slides the intermediate member relative to the base in asecond direction different from the first direction.
 7. A systemaccording to claim 1, wherein arm pivots relative to the base through anarc of between 10 degrees and 30 degrees.
 8. A system according to claim1, wherein arm pivots relative to the base through an arc ofapproximately 20 degrees.
 9. A system according to claim 1, wherein: thearm includes a notch extending along at least a portion of the length ofthe arm; and the intermediate member includes a protrusion that slideswithin the notch as the intermediate member slides along the arm.
 10. Asystem according to claim 1, wherein: the threaded portion of the armincludes a thread member; and the notch extends through the threadmember.
 11. A gas delivery mask apparatus, comprising: a rigid maskbase; a face mask configured to deliver gas to the subject; and a rigidmask arm rotationally coupled to the mask base proximate a first end bya pivot joint having an axis extending laterally across the mask base,the rigid mask arm coupled to the face mask proximate a second end andconfigured to support a flexible gas flow tube for delivering gas to theface masks; wherein at least a portion of the flexible gas flow tubeextends along a length of the rigid mask arm between the pivot joint andthe face mask.
 12. A mask apparatus according to claim 11, furthercomprising an intermediate member coupled to the mask base and the maskarm, wherein the intermediate member may be manipulated to rotate themask arm about the pivot joint and relative to the mask base to vary adistance between the face mask and the subject's face.
 13. A maskapparatus according to claim 12, wherein the intermediate membercomprises a sleeve disposed around the mask arm.
 14. A mask apparatusaccording to claim 12, wherein: the mask arm includes a first threadedportion; and the intermediate member includes a second threaded portioncoupled with the first threaded portion of the mask arm such thatrotation of the second threaded portion relative to the first threadedportion rotates the mask arm about the pivot joint and relative to themask base.
 15. A mask apparatus according to claim 14, wherein rotationof the second threaded portion slides the intermediate member along themask arm and relative to the mask base such that the mask arm pivotsabout the pivot joint and relative to the mask base.
 16. A maskapparatus according to claim 14, wherein: the mask base includes anelongated notch; and the intermediate member includes a peg slidablycoupled to the elongated notch.
 17. A mask apparatus according to claim16, wherein rotation of the second threaded portion relative to thefirst threaded portion slides the peg along the elongated notch.
 18. Amask apparatus according to claim 14, wherein: the intermediate memberincludes an elongated notch; and the mask base includes a peg slidablycoupled to the elongated notch.
 19. A mask apparatus according to claim14, wherein rotation of the second threaded portion relative to thefirst threaded portion slides the intermediate member along the mask armin a first direction and slides the intermediate member relative to themask base in a second direction different from the first direction. 20.A gas delivery mask, comprising: a mask base; a mask arm rotationallycoupled to the mask base and including a first threaded portion; and anintermediate mask member coupled to the mask base and the mask arm, theintermediate mask member including a second threaded portion coupledwith the first threaded portion of the mask arm such that rotation ofthe second threaded portion relative to the first threaded portionrotates the mask arm relative to the mask base.
 21. The mask of claim20, wherein rotation of the second threaded portion slides theintermediate mask member along the arm and relative to the base suchthat the arm pivots relative to the base.
 22. A system for adjusting agas delivery mask, the system comprising: rigid base means forsupporting a gas delivery mask adjacent a subject's head; gas deliverymeans for delivering gas to the subject; elongated rigid supportingmeans for supporting the gas delivery means, the rigid supporting meansbeing rotatably coupled to the rigid base means about a pivot jointhaving an axis extending laterally across the rigid base means; androtating means having a first portion slidably coupled to the elongatedrigid supporting means such that rotation of the rigid supporting meanscauses the first portion of the rotating means to slide along a lengthof the elongated rigid supporting means.
 23. A system according to claim22, wherein the rotating means includes a second portion slidablycoupled to the rigid base means.
 24. A breathing facilitation system forfacilitating or affecting a subject's breathing, comprising: a gassource configured to deliver gas; an adjustable mask apparatus; and oneor more gas delivery conduits configured to deliver gas from the gassource to a subject via the adjustable mask apparatus; wherein theadjustable mask apparatus comprises: a base; an arm pivotally coupled tothe base, the arm including a first threaded portion; and anintermediate member slidably coupled to both the base and the arm, theintermediate member including a second threaded portion coupled to thefirst threaded portion, wherein rotation of the second threaded portionrelative to the first threaded portion slides the intermediate memberalong the arm and relative to the base such that the arm pivots relativeto the base.